Randomization Should Be Disclosed to Potential Research Subjects

摘要

One of the questions raised by the SUPPORT study is,what information should be disclosed to potential research subjects? Wendler (2013) argues that potential research subjects should be told that they are being asked to contribute to a research study designed to collect information to help others (and not uniquely-or primarily-the research subject). Researchers should also disclose information about the net risks of the study, that is, risks that are not compensated by an increased potential for clinical benefit. Otherwise, information disclosed about the procedures in a study should be similar to the information disclosed to patients in the clinical setting (Wendler 2013). Wendler claims that one of the implications of this argument is thatwhen clinical equipoise obtains, there is no need to disclose randomization to potential research subjects.We argue thatWendler's argument concerning randomization is not persuasive. The concept of clinical equipoise has no definitive bearing on disclosure standards in clinical research. A potential research subject's ability to make informed decisions about trial participation depends on researchers disclosing information about the procedures, risks, benefits, and methods of a trial, including randomization.